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Subject Matter Expert Mass Spectrometry Job Netherlands,
Posted on : 10 April 2017
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- The Global Vaccines and Biologics Commercialization (GVBC) supports the commercialization of vaccines and biotechnological derived pipeline products.
- Furthermore, GVBC has a crucial role in supporting vaccines and biologics Lines of Business (LoB) and the Quality Organization.
- As part of the GVBC organization analytical and process Centers of Excellence are located in the US.
- These teams are regionally responsible for support to LoB and Quality and introducing new processes and analytical methods into the commercial operations space.
- Reporting into the Team Lead SME s the Subject Matter Expert Mass Spectrometry holds a Subject Matter Expert (SME) role for mass spectrometry analysis.
- The individual oversees all mass spectrometry efforts from a scientific perspective and is able to translate current thinking and new advances into our analytical portfolio.
- In that role the person establishes and maintains an internal and external network of mass spectrometry experts.
- Furthermore he or she indirectly guides all mass spectrometry related activities in the department and provides significant input into regulatory documents and response to questions.
- This position does not have direct reports.
Roles and responsibilities include:
Scientific and Technical leadership (60% of average time spent)
- Analytical SME, with deep scientific understanding of all mass spectrometry methods used for characterizing biotechnological products;
- Responsible for best scientific practices within the lab space and supports from an extended characterization perspective troubleshooting, process support and life cycle management activities;
- Writes complex technical documentation used for regulatory filings (e.g. Justification of specifications, process characterization summaries);
- Recruitment and supervision of MSc-level students.
Project leadership (40% of average time spent)
- Participates in cross-functional/global CMC project teams and leads derived subteams (e.g. working groups responsible for analytical or drug substance development workstreams);
- Participates as SME in solving technical problems at an international level;
- Root Cause Analysis lead for significant investigations (regional).
- PhD in biological sciences, biochemistry, or biochemical engineering or equivalent through experience;
- Minimum of 5-10 years relevant experience in protein analytics;
- Significant experience in analytical methodologies for quality control of biotechnological products;
- Strong project management skills & proven ability to manage complex projects;
- Knowledge of regulatory and quality guidelines, and knowledge on CTD format for IND/ BLA/ MAA submissions preferred;
- Excellent analytical and technical skills;
- Demonstrated initiative, and innovative process-oriented thinking within a team environment;
- Strong oral and written communication skills in English (required), Dutch or willing to learn Dutch is a plus.
A good place to work
- Our employees are the key to our company s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives
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